Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06249633
• Other study ID #: STUDY00001807
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 2024
• Est. completion date: February 2026

Study information

• Verified date: January 2024
• Source: Cedars-Sinai Medical Center
• Contact: Emine Gholian
• Phone: 310-423-8474
• Email: grouplungresearch[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ARDS based on the Berlin criteria
• Mechanically ventilated
• Age = 18 years

Exclusion Criteria:

• Primary cardiogenic shock
• History of more than mild pulmonary hypertension preceding ARDS diagnosis
• Presence of pre-existing significant valvular disease
• Presence of pre-existing left ventricular dysfunction or significant hypertrophy
• Consent cannot be obtained from the patient or his/her surrogates
• Refusal of consent
• Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Nitric Oxide
Inhaled nitric oxide

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Yuri Matusov	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining improvement in pulmonary artery pressure in response to iNO	Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.	Approximately 4 days
Primary	Determining improvement in tricuspid annular plane systolic excursion in response to iNO	Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.	Approximately 4 days
Primary	Determining improvement in right ventricular fractional area change in response to iNO	Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.	Approximately 4 days
Secondary	Improvement in urine output in response to iNO	Urine output changes will be determined by continuous bedside evaluation of urine output (in ml/hr) before and after initiation of iNO.	Approximately 4 days
Secondary	Improvement in serum creatinine in response to iNO	Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO.	Approximately 4 days